Summit Technology Press Release - CustomCornea®
First Human Laser Vision Correction Surgery Using Autonomous CustomCornea® Wavefront Technology Performed by Marguerite McDonald, MD
Waltham, Massachusetts (October 15, 1999) - Summit Technology, Inc. (NASDAQ: BEAM) announced today that Marguerite McDonald, MD has performed the first customized laser vision correction in the United States using the Autonomous LADARVision® System and proprietary CustomCornea® wavefront measurement technology. In July of this year, Autonomous was granted an Investigational Device Exemption (IDE) by the US Food and Drug Administration (FDA) to begin clinical trials of its CustomCornea® wavefront technology on nearsighted, farsighted and astigmatic patients using both photorefractive keratectomy (PRK) and laser in-situ keratomelieusis (LASIK). The investigational procedure was performed in connection with these clinical trials. CustomCornea® is the first wavefront measurement device of its kind to begin clinical studies in the United States and Dr. McDonald's investigational procedures mark the first human surgeries performed using this technology.
Current laser vision correction techniques reshape the cornea to a standard spherical shape based on the patient's manifest refraction, which is the trial lens measurement technique used in determining a contact lens or spectacle prescription. This 100 year old measurement technique relies on a subjective input of the patient rather than on objective scientific data.
By using the CustomCornea® wavefront sensing measurement device developed by Autonomous, Dr. McDonald was able to objectively measure the unique optical aberrations in each patient's eyes and treat the patient with a customized ablation pattern to reshape the cornea. The customized ablation was applied to the cornea using the Autonomous LADARVision® System. The LADARVision® System is currently the only FDA approved laser vision correction system to utilize a narrow beam scanning laser and a sophisticated eye-tracker, which compensates for involuntary eye movement during the surgery. Customized ablations are intended to improve the outcome of laser vision correction surgery.
The five patients treated underwent LASIK surgery this week for the correction of nearsightedness. Commenting after the surgery, Dr. McDonald stated,
"Today is a watershed moment in laser refractive surgery. This is probably as important a milestone as the development of laser surgery, it is that much of an improvement on current technology."
The Company believes that its CustomCornea® technology will provide surgeons with the ability to treat ocular aberrations that cannot be detected or compensated for by existing refractive systems.
"Our goal is to greatly improve the quality of vision for patients after refractive surgery and to potentially go beyond the current 20/20 visual acuity standard, setting a new level of expectation for refractive surgery outcomes,"
said Randy Frey, President of the Company's Autonomous subsidiary and Executive Vice President of Summit.
Initial clinical results from the IDE study will be announced October 23, 1999, at a special session of the International Society of Refractive surgeons in Orlando, Florida.
Founded in 1995, Summit Technology is a leading developer, manufacturer and marketer of ophthalmic laser systems and related products designed to correct common vision disorders such as nearsightedness, farsightedness and astigmatism. In 1995, Summit was the first excimer laser company to receive FDA approval for its excimer laser system for the correction of mild to moderate myopia in the U.S. Autonomous, a wholly owned subsidiary, is engaged in the design and development of next-generation excimer laser instruments for laser refractive surgery. The Company's LADARVision® System combines laser radar eye tracking with narrow beam shaping technology. In addition, through its wholly owned subsidiary, Lens Express, Summit sells contact lenses and related products.
Cautionary Statement: Under "Safe Harbor" Provisions of The Private Securities Litigation Reform Act Of 1995: Statements made in this news release contain information about the Company's future business prospects. These statements may be considered "forward-looking". These statements are subject to risks and uncertainties that could cause actual results to differ materially from those set forth in or implied by such forward-looking statements. Among these risks and uncertainties are: competition from other manufacturers and vision correction technologies, delays in obtaining regulatory approvals, challenges to patents owned and licensed by the Company affecting per procedure revenues, adverse litigation results, difficulties in commercializing the LADARVision system and dependence on sole source suppliers. For additional information and risks associated with the Company's business prospects and future operating results, please refer to Summit's public filings with the Securities and Exchange Commission.
Created October 27, 1999.